Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil on Anesthesia in Endoscopic Sinus Surgery

Comparision Between Hemodynamic Response of Dexmedetomidine and Remifentanil for Epinephrine Local Injection in Patient With Endoscopic Sinus Surgery Under General Anesthesia

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk. This study is comparing of dexmedetomidine and remifentanil before epinephrine local injection for controlled hypotension during ESS.

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Epinephrine; Drug: Propofol; Drug: Rocuronium; Drug: Remifentanil

Detailed Description

During endoscopic sinus surgery (ESS), epinephrine local injection and controlled hypotension is essential in order to increase the visibility in the operative field and reduce the risk.

Epinephrine local injection and controlled hypotensive anesthesia is commonly used in several surgical interventions using different techniques. However, choosing the ideal agent is still a controversial topic.

In the current study, the effects and safety of remifentanil, which is an μ opioid receptor agonist and dexmedetomidine, an α-2 agonist; when used before epinephrine local injection for controlled hypotension in ESS, are compared.

After obtaining Institutional Review Board approval and written informed consent, 40 patients is enrolling in this study.

Participants is divided by two groups randomly as the Dexmedetomidine group and the Remifentanil group.

A correctly sized facemask and 100 % oxygen was used for pre-oxygenation. General anesthesia was induced with iv Propofol 1.5-2 mg kg-1. Endotracheal intubation was performed with the aid of iv Rocuronium 0.6 kg-1. Ventilation was controlled with 50% air in oxygen to maintain end-tidal carbon dioxide pressure at 30-36 mmHg. Desflurane was used for maintenance.

Before epinephrine injection, In group Remifentanil, Participants received 1 mcg kg-1 iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4 mcg kg-1 h-1. The infusion rate was adjusted according to the Participants response, to achieve a mean arterial pressure between 60 and 75 mmHg. In group Dexmedetomidine, patients received a 1 mcg kg-1 loading dosage of dexmedetomidine within 10 min and later, infusion was started at the rate of 0.4-0.8 mcg kg-1min-1. The infusions began before tracheal intubation in both groups. Standard dose epinephrine local infiltration was administered to the nasal passages by the surgeon.

Systolic Arterial Pressure,Diastolic Arterial Pressure,Mean arterial blood pressure, Heart Rate were recorded every 5min, from the beginning of anesthesia and every 1min, from the epinephrine local injection. Perioperative hypotension and bradycardia were defined as mean arterial blood pressure < 50 mmHg or 50 beat/min respectively. Ephedine was administered intravenously for the treatment of hypotension. Atropine 0.5 mg was administered intravenously for the treatment of bradycardia.

All infusions were stopped 5 min before the end of surgery. After surgery, the surgeon evaluated the dryness of the surgical area. Recovery time was recorded in the postoperative period. An investigators employing the Modified Observer's Assessment of Alertness/Sedation Scale assessed recovery.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologist[ASA] class 1-2
• scheduled Endoscopic sinus surgery
• written informed consent

Exclusion Criteria:

• allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
• known or suspected upper respiratory infection
• suspected difficult tracheal intubation
• Uncontrolled Hypertension
• known or suspected psychologic disorder
• known or suspected significant renal dysfunction
• known or suspected severe hepatic dysfunction
• known or suspected significant cardiovascular dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Before induction of Anesthesia, 1 mcg/kg iv loading dose of dexmedetomidine over 10 minutes.; Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1; After Mask ventilation with 6 vol% desflurane in 100% oxygen for 3 minutes, tracheal intubation was done; Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.; Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.; At the end of surgery, discontinuation of desflurane and dexmedetomidine, sending recovery room.	Drug: Dexmedetomidine; 1 mcg/kg iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min.; Other Names: dexmedetomidine hydrochloride; Drug: Epinephrine; Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.; Drug: Propofol; Anesthesia was induced with propofol 2 mg kg-1; Drug: Rocuronium; Anesthesia was induced with rocuronium 0.6 mg kg-1
Active Comparator: Remifentanil; Anesthesia was induced with propofol 2 mg kg-1 , rocuronium 0.6 mg kg-1; Mask ventilation with 6 vol% desflurane in 100% oxygen for 2 minutes.; After 1 mcg/kg iv loading dose of remifentanil over a period of 1 minutes. tracheal intubation was done.; Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min. The infusion rate was adjusted according to the patient's response, to achieve a mean arterial pressure between 60 and 80 mmHg.; Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.; At the end of surgery, discontinuation of desflurane and remifentanil, sending recovery room.	Drug: Epinephrine; Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.; Drug: Propofol; Anesthesia was induced with propofol 2 mg kg-1; Drug: Rocuronium; Anesthesia was induced with rocuronium 0.6 mg kg-1; Drug: Remifentanil; 1 mcg/kg iv loading dose of remifentanil over a period of 10 minutes. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min.; Other Names: remifentanil hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure	At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conditions during Surgery	We assessed conditions during ESS(Surgeon evaluated the dryness of the surgical area using six point quality scale.)	At the time during Surgery

Other Outcome Measures

Outcome Measure	Time Frame
Change in heart rate	At the time from epinephrine local injection (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes)

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: Jangeun Cho, M.D, Ph.D, Anesthesia and pain medicine department, Korea University Anam Hospital

Publications and helpful links

General Publications

• Lee J, Kim Y, Park C, Jeon Y, Kim D, Joo J, Kang H. Comparison between dexmedetomidine and remifentanil for controlled hypotension and recovery in endoscopic sinus surgery. Ann Otol Rhinol Laryngol. 2013 Jul;122(7):421-6. doi: 10.1177/000348941312200702.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: July 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Remifentanil; Dexmedetomidine; Endoscopic sinus surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Neuromuscular Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Remifentanil; Propofol; Dexmedetomidine; Epinephrine; Rocuronium
• Other Study ID Numbers: ED15010